Actively Recruiting
Phase 3 Study of Nipocalimab Compared to Placebo in Adults With Moderate to Severe Systemic Lupus Erythematosus
Led by Janssen Research & Development, LLC · Updated on 2026-07-31
600
Participants Needed
231
Research Sites
152 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating nipocalimab compared to a placebo in adults with moderate to severe systemic lupus erythematosus SLE, a chronic disease where the immune system attacks healthy tissues causing swelling and redness in various organs. This Phase 3 study aims to understand how well nipocalimab works in treating SLE symptoms and disease activity. Participants will receive either nipocalimab or a placebo alongside standard care treatments during a double-blind treatment period lasting up to 52 weeks. After this period, eligible participants from both groups may enter an open-label long-term extension phase to continue nipocalimab treatment until Week 156 or until discontinuation. Throughout the study, participants will undergo assessments including measurement of disease activity, joint pain, fatigue, and flare status. Researchers will monitor responses such as the SLE Responder Index at Week 52, and track safety and treatment adherence. The total participation duration may extend up to approximately three years including the extension phase.
CONDITIONS
Brief Title
A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
Research Team
S
Study Contact
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